CQV Workstream Lead - Project Manager

PSC Biotech • York Township, PA

3d • Remote

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.

Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it’s about more than just a job—it’s about your career and your future.

Your Role

We are hiring a motivated CQV Workstream Lead to join our team! The CQV Workstream Lead will oversee commissioning, qualification, and validation (CQV) activities for a major biopharmaceutical manufacturing expansion project. This role provides strategic and technical leadership across multiple equipment and process areas, ensuring all systems meet regulatory, quality, and operational readiness requirements. The ideal candidate brings deep expertise in large‑scale CQV execution, biologics drug‑product manufacturing, along with strong leadership and project‑management capabilities.

This is a flexible role with remote/hybrid options, with travel and on-site presence required during ongoing project phases. Candidates must be willing to travel throughout the East Coast / Midwest.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of commissioning, qualification, and validation experience in GMP biopharmaceutical environments.
• Hands‑on experience with bulk manufacturing processes and associated equipment.
• Demonstrated background in cleaning circuits, cleaning validation, and CIP lifecycle development.
• Strong leadership and project‑management capabilities managing complex, multi‑workstream CQV programs.
• Experience with risk‑based CQV approaches and electronic validation systems such as KNEAT.
• Excellent communication, stakeholder‑management, and technical problem‑solving skills.
• Must be authorized to work in the U.S.
• Ability and willingness to travel/work fully onsite as the project progresses.

Responsibilities

• Lead all CQV workstream activities across facilities, utilities, equipment, and manufacturing systems for a large‐scale biopharmaceutical expansion project.
• Develop, manage, and execute CQV strategy, schedules, deliverables, and resource plans in alignment with project objectives and regulatory expectations.
• Oversee commissioning and qualification of biopharmaceutical process equipment, including tanks/vessels, CIP skids, etc.
• Apply risk‑based CQV methodologies and ensure compliance with GMP, FDA, EMA, and global regulatory requirements.
• Lead and coordinate cross‑functional teams—including engineering, operations, quality, and automation—and provide technical direction to validation personnel and vendors.
• Ensure that all CQV documentation (URS, FAT/SAT support, IV/OV/PQ, risk assessments, protocols, reports) is generated, reviewed, and approved.
• Utilize KNEAT or similar systems for electronic validation lifecycle management.
• Identify project risks, develop mitigation strategies, and drive resolution of technical or schedule barriers.
• Provide ongoing communication to project leadership and stakeholders regarding progress, challenges, and readiness milestones.

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• 401(k) and 401(k) matching
• PTO, Sick Time, and Paid Holidays
• Education Assistance
• Pet Insurance
• Discounted rate at Anytime Fitness
• Financial Perks and Discounts

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 51-100 employees